Roche acquires IQuum to strengthen offerings in molecular diagnostics
IQuum’s unique products will allow Roche to quickly enter the point of care segment of molecular diagnostics. Roche announced today the acquisition of IQuum, Inc. based in Marlborough, Massachusetts, USA. IQuum is a privately held company focused on developing point of care offerings for the molecular diagnostics market. Under the terms of the agreement, Roche will pay IQuum shareholders USD 275 million upfront and up to USD 175 million in contingent product related milestones. The transaction is subject to customary closing conditions.
FDA approves Xolair (omalizumab) for people with Chronic Idiopathic Urticaria, a form of chronic hives
Roche today announced that the U.S. Food and Drug Administration (FDA) approved Xolair (omalizumab) for the treatment of chronic idiopathic urticaria (CIU), a form of chronic hives. The new use is for people 12 years of age and older who remain symptomatic despite treatment with H1-antihistamine therapy. Until now, H1-antihistamines have been the only approved therapy for CIU, with about 50 percent of patients having an inadequate response.
FDA Advisory committee unanimously recommends Roche's HPV Test as primary screening tool for detection of women at high risk for cervical cancer
Roche announced today that the U.S. Food and Drug Administration (FDA) Microbiology Devices Panel of the Medical Devices Advisory Committee recommended unanimously that the benefits of the cobas HPV (Human Papillomavirus) Test as a first line, primary screening tool in women 25 years and older to assess their risk of cervical cancer based on the presence of clinically relevant high-risk HPV DNA outweigh the risks. The panel also voted unanimously that the cobas HPV Test is safe and effective for the proposed indication for use. If approved, the cobas HPV Test would become the first and only HPV test indicated as the first-line primary screen of cervical cancer in the United States.
New Roche test helps specialists to identify syphilis in routine samples and donated blood
Diagnostics division strengthens its position in the serology market and expands its immunoassay portfolio in infectious disease. Roche today announced the market availability of the Elecsys Syphilis immunoassay, a diagnostic test to help detect patients infected with syphilis in routine clinical practice and to make sure donated blood is not infected with syphilis.